The Effect on Fluid Balance After Cardiac Surgery After Use of Two Different Priming Protocols

Coronary Heart Disease Clinical Trial

Official title:

Ringer`s Acetat Versus Balanced Hydroxyethyl-starch as Primesolution in the Heart-lung Maschine During Cardio-pulmonary-bypass. Postoperatively Fluid Balance and Cardiac Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511120
• Other study ID #: 2011/498
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2011
• Last updated: May 11, 2015
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: August 2013
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial Summary

"The impact on fluid loading after cardiac surgery by use of two different priming solution"

Fluid overloading with oedema formation is a regular finding following on-pump cardiac surgery and may contribute to postoperative organ dysfunction. Myocardial oedema has been reported to impair both systolic and diastolic function. An association between intraoperative fluid loading and postoperative adverse outcome has been demonstrated in cardiac patients.

The investigators have experience with the use of both colloides and combination fluids (hypertonic saline/colloides) in several experimental studies (pigs). In one animal study the investigators used colloides as an additive to the CPB-prime. The investigators observed reduced fluid leakage and less total tissue water in several organs.

The planned study includes patients scheduled for coronary artery bypass, and who have no co-morbidity. The patients will be randomized to receive either Tetraspan® (HES) or acetated Ringer`s solution in the CPB-prime. Accurate accounts of fluid additions, blood loss and diuresis will be kept. Determination of cardiac output (C.O.), intrathoracic blood volume (ITBV), extravascular lung water (EVLW) and global end diastolic volume (GEDV) will be monitored by use of the transpulmonary thermodilution technique PiCCO®plus system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing CABG,

• EF(ejection fraction) more than 40%

Exclusion Criteria:

• Reduced EF (less than 40%) EVF less than 30%,

• Estimated GFR less than 60%,

• BMI less than 18 or more than 32

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Tetraspan

• acetated Ringer`s solution

Locations

Country	Name	City	State
Norway	Hjerteavdelingen, thoraxkirurgisk seksjon, Haukeland Universitetssykehus	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of organ edema and improved organ function	As a target of effect the investigators have chosen to study improvements for organ function.Indexed values for cardiac output(CI) measured by the PICCO system will be a parameter for heart function, andf lung function will be measured by EVLWI(extravascular lungwater index).paO2/FiO2-ratio and time spent in respirator.Additionally a strict account for fluid balance will be kept.	6-hours postoperatively	No